Simultaneous estimation of olopatadine hydrochloride and Ketorolac tromethamine in bulk and pharmaceutical dosage form by RP-HPLC method

Abstract

A new analytical RP-HPLC chromatographic method was developed and validated for the simultaneous estimation of Olopatadine Hydrochloride (OPH) and Ketorolac Tromethamine (KLT) in bulk drug and pharmaceutical dosage forms. The method was validated as per ICH guidelines. The separation was carried out by using a mobile phase consisting of buffer: acetonitrile in the ratio of 50: 50. The column used was inertsil ODS C₁₈ (4.6×250mm) 5µ with flow rate of 1.0 ml / min using UV detector at 260 nm. The described method was linear over a concentration range of 2.5-15.0 μg/ml for OPH (r² =0.999) and 10-60 μg/ml for KLT (r² =0.999). The retention times were found to be 2.7 min for OPH and 3.8 min for KLT. The limit of detection (LOD) was found to be 0.11 μg/ml for OPH and 0.94 μg/ml for KLT. The limit of quantification (LOQ) was found to be 0.36 μg/ml for OPH and 2.80 μg/ml for KLT. The study results showed that the proposed RP-HPLC method is simple, sensitive, rapid, precise, accurate and specific, which is useful for the routine simultaneous determination of OPH and KLT in its dosage form.